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Volcano Highlights Commitment, Market Acceptance of FFR Product Line
Company expects market awareness of FAME data will fuel continued growth in PrimeWire™ and s5-FFR console demand
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January
20, 2009, San Diego -- Volcano Corporation (Nasdaq:
VOLC), a leader in the development, manufacturing and sales of
products for the diagnosis and treatment of coronary and peripheral
artery disease, today commented on the increased demand for their
FFR and IVUS capable consoles, as well as their FFR pressure
guide wires following the TCT announcement of the FAME study
results.
Joe Burnett, Vice President of Marketing at Volcano Corp commented:
"The
rapid market acceptance of the FAME data, and heightened awareness around
FFR guided PCI technique has been captured clearly by the increased interest
in our pressure guide wires and FFR functionality on our s5 family of
imaging consoles. Since the FAME study was presented in at the TCT in
October, we have experienced growing receptivity in the market to our
FFR offerings. The FFR option for our s5i integrated imaging console
was included in more than 90% of all new orders, which is again evidence
that physicians and hospitals are demanding access to this reinvigorated
technology. The expanding FFR capable installed
base, and the increased procedural speed of FFR systems that are physically
integrated into each cath lab room, is further fueling the impact of
FAME."
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Doppler Guide
Wire,
measuring FFR inside
coronary artery
image courtesy of
Volcano Corporation |
The FAME study, published in the New England
Journal of Medicine, demonstrated that using FFR guidance in
addition to angiography can reduce mortality and myocardial infarction
by
34% at one year. The study also demonstrated that these improved
clinical outcomes were complemented by reduced cost to the hospitals
involved in the trial. "The FAME study is among the most important studies in today's DES therapy era. FAME demonstrates that when physicians employ FFR to guide multi-vessel PCI treatment, their patients benefit both clinically and economically. The FFR-guided interventions for multi-vessel disease are also cost effective for hospitals and payers. FAME confirms the benefits of routine FFR for the multi-vessel patient just as the earlier Deferral versus Performance of PTCA in Patients Without Documented ischemia (DEFER) study demonstrated in single-vessel disease, but does so in a larger patient population and in a randomized fashion," commented
Morton Kern, MD, professor of medicine and associate chief, Division
of Cardiology, University of California, Irvine.
FAME randomized 1005 patients diagnosed with multi-vessel coronary artery disease at 20 European and US centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current DES regimens. FAME's objective was to compare angiographic guidance to FFR guidance and to determine which coronary lesions required revascularization. FAME demonstrated that FFR-guidance in routine multi-vessel PCI resulted in clinically-superior outcomes and reduced the composite of death, documented myocardial infarction, and repeat revascularization by 30 percent at one year. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost beneficial to the hospital and payers by reducing procedural costs ($5,332 vs. $6,007), lowering average length of hospitalization (3.4 days vs. 3.7 days), and reducing the number of drug eluting-stents necessary per patient (1.9 vs. 2.7). The data also showed that the implementation of FFR did not add time to the multi-vessel PCI procedure.
"Angiography alone does not tell the whole story, and can even be misleading," continued Burnett. "FFR
is now a well validated and readily available tool, which can quickly
guide physicians to ischemia producing lesions that benefit most
from stent placement. The number of multi-vessel disease cases worldwide
is significant, and if adopting FFR can both improve patient outcomes
and reduce hospital costs, we believe we are at the very beginning
of market penetration given today's economic environment."
Volcano Corporation
Volcano Corporation (Nasdaq: VOLC) offers a broad suite of devices
designed to facilitate endovascular procedures, enhance the diagnosis
of vascular and structural
heart disease and guide optimal therapies. The company's intravascular ultrasound
(IVUS) product line includes ultrasound consoles that can be integrated directly
into virtually any modern cath lab. Volcano IVUS offers unique features, including
both single-use phased array and rotational IVUS imaging catheters, and advanced
functionality options, such as VH® IVUS tissue characterization and ChromaFlo®.
Volcano also provides functional measurement (FM) consoles and single-use pressure
and flow guide wires and is developing a line of ultra-high resolution Optical
Coherence Tomography (OCT) systems and catheters. Currently, more than 3,700
Volcano IVUS and FM systems are installed worldwide, with approximately half
of its revenues coming from outside the United States. For more information,
visit the company's website at http://www.volcanocorp.com
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Any statements in this release regarding Volcano's business that
are not historical facts may be considered "forward-looking statements," including
statements regarding the features, functionality and potential benefits
of our products and patient outcomes, market awareness, acceptance
and adoption of the company's technology, the impact of clinical
and other technical data, the safety, cost and efficacy of the company's
products, the success and timing of product development and clinical
trial programs, growth and market development, and product sales.
Forward-looking statements are based on management's current preliminary
expectations and are subject to risks and uncertainties, which may
cause Volcano's results to differ materially and adversely from the
statements contained herein. Some of the potential risks and uncertainties
that could cause actual results to differ from the results predicted
are detailed in the company's annual report on Form 10-K, quarterly
reports on Form 10-Q and other filings made with the Securities and
Exchange Commission. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. Volcano
undertakes no obligation to update any forward-looking statements
to reflect new information, events or circumstances after the date
they were made, or to reflect the occurrence of unanticipated events.
Source: Volcano Corporation
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